FDA 510(k) Applications for Medical Device Product Code "FLD"
(Apparatus, Hemoperfusion, Sorbent)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K971015 | AMERICAN HEALTH CARE SYSTEMS, INC. | AHCS HEMOPERFUSION SYSTEM | 10/22/1997 |
| K033262 | GAMBRO RENAL PRODUCTS | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) | 05/27/2005 |
| K133807 | GAMBRO RENAL PRODUCTS, INC. | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT | 03/26/2014 |
| K113313 | GAMBRO RENAL PRODUCTS, INC. | MOLECULAR ADSORBENT RECIRCULATING(MARS) | 12/14/2012 |
| K984546 | HEMOCLEANSE, INC. | BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK | 08/13/1999 |
| K953751 | HEMOCLEANSE, INC. | BIOLOGIC-DT SYSTEM | 02/15/1996 |
| K992196 | HEMOCLEANSE, INC. | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) | 09/10/1999 |
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